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FDA Warns Hand Sanitizer Companies: Stop ‘Unproven’ MRSA Claims

FDA Warns Hand Sanitizer Companies

The Food and Drug Administration announced that it issued Warning Letters to four companies that manufacture or distribute types of hand sanitizers and antiseptic products that inaccurately claim that they can prevent MSRA infections. The following four companies were issued Warning Letters:

1. Staphaseptic First Aid Antiseptic/Pain Relieving Gel, by Tec Laboratorie

2. Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates

3. Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.

4. Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company.

The FDA is concerned that these products are giving consumers a false sense of protection. Unproven claims found on product labels include, but are not limited to such claims as “kills over 99.9% of MRSA”; “helps prevent skin infections caused by MRSA and other germs”; “is effective against a broad spectrum of pathogens, including MRSA.”

MSRA is a very serious problem. It is a bacterium that can cause severe infections that may become life-threatening. Most troubling is that these infections do not respond to standard treatment with the antibiotic methicillin. According to Edward Cox, M.D., M.P.H., director of the FDA Office of Antimicrobial Products, MRSA is extremely difficult to treat.

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